Brief Title
Heart Failure and Aortic Stenosis Transcriptome
Official Title
Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis
Brief Summary
This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers. To this purpose, both tissue and blood specimens will be collected and patients will be compared to individuals not affected by cardiovascular diseases.
Detailed Description
The investigators will collect plasma and cardiac tissue specimens from consenting subjects. The investigators will evaluate the expression of mRNAs, miRNAs and lncRNAs in patients affected by both end-stage and not end-stage HF as well as in patients affected by aortic stenosis and undergoing valve replacement and requiring cardiac myectomy. The tissue dysregulated RNAs will be next measured in plasma samples in order to clarify their potential as biomarkers.
Study Type
Observational
Primary Outcome
Cardiac tissutal mRNAs signatures
Secondary Outcome
Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas
Condition
Heart Failure
Intervention
measurement of RNAs
Study Arms / Comparison Groups
Non end-stage heart failure
Description: Measurement of RNAs in non end-stage heart failure patients undergoing to left ventricle reconstruction
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
500
Start Date
June 30, 2016
Completion Date
June 30, 2021
Primary Completion Date
June 30, 2019
Eligibility Criteria
Inclusion Criteria: 1. Non end-stage heart failure - left ventricle restoration surgery (SVR) - End Systolic Volume Index (ESVI) >35 ml/m2 - Ejection Fraction (EF)<40% - previous transmural anterior myocardial infarction (MI) - age: 40-75 2. End-stage heart failure - left ventricle assisted device (LVAD) surgery - age: 40-75 - Ejection Fraction (EF) <25% - End Systolic Volume Index (ESVI)≥60 ml/m2 3. Aortic Stenosis - aortic valve replacement - intracardial pressure difference >40 mmHg - septal diameter ≥1.3 cm Exclusion Criteria: 1. Non end-stage heart failure - End Systolic Volume Index (ESVI)<35 ml/m2 - Ejection Fraction (EF)>40% - Time from MI unknown - Pregnancy - Other genetic diseases - Neoplasms - Collagenopathies - Chemo/radiotherapy - Prolonged use of corticosteroids - Infections - Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive 2. End-stage heart failure - EF>25% - Time from MI unknown - Pregnancy - Other genetic diseases - Neoplasms - Collagenopathies - Chemo/radiotherapy - Prolonged use of corticosteroids - Infections - Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive 3. Aortic Stenosis - coronaropathies - Pregnancy - Other genetic diseases - Neoplasms - Collagenopathies - Chemo/radiotherapy - Prolonged use of corticosteroids - Infections - Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
Gender
All
Ages
40 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Fabio Martelli, Dr, +39 02 26437762, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT03268135
Organization ID
RNA-HF-AS
Responsible Party
Principal Investigator
Study Sponsor
IRCCS Policlinico S. Donato
Collaborators
Ospedale San Raffaele
Study Sponsor
Fabio Martelli, Dr, Principal Investigator, IRCCS-POLICLINICO SAN DONATO
Verification Date
February 2020